Agenda of the PRAC meeting 10-13 February 2025
Submitted by Anonymous (not verified) on 10 February 2025 - 15:47
Agenda of the PRAC meeting 10-13 February 2025
Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance
Submitted by Anonymous (not verified) on 10 February 2025 - 13:40
Methylphenidate, prolonged-release tablet 18 mg, 27 mg, 36 mg and 54 mg and modified release capsule 5 mg, 10 mg, 20 mg, 30 mg, 40 mg, 50 mg and 60 mg product-specific bioequivalence guidance
List of signals discussed at PRAC since September 2012
Submitted by Anonymous (not verified) on 10 February 2025 - 12:30
List of signals discussed at PRAC since September 2012
Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 5 December 2024, 09:30 (CET) to 5 December 2024, 13:30 (CET)
Submitted by Anonymous (not verified) on 10 February 2025 - 12:19
Meeting of the Medicine Shortages Single Point of Contact (SPOC) Working Party, Online, from 5 December 2024, 09:30 (CET) to 5 December 2024, 13:30 (CET)
Pharmacovigilance Risk Assessment Committee (PRAC): 25 - 28 November 2024, European Medicines Agency, Amsterdam, the Netherlands, from 25 November 2024 to 28 November 2024
Submitted by Anonymous (not verified) on 10 February 2025 - 12:01
Pharmacovigilance Risk Assessment Committee (PRAC): 25 - 28 November 2024, European Medicines Agency, Amsterdam, the Netherlands, from 25 November 2024 to 28 November 2024
Minutes of the PRAC meeting 25-28 November 2024
Submitted by Anonymous (not verified) on 10 February 2025 - 11:58
Minutes of the PRAC meeting 25-28 November 2024
ACT EU multi-stakeholder platform annual meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 October 2024, 09:30 (CEST) to 22 October 2024, 17:00 (CEST)
Submitted by Anonymous (not verified) on 10 February 2025 - 11:55
ACT EU multi-stakeholder platform annual meeting, Online, European Medicines Agency, Amsterdam, the Netherlands, Broadcast, from 22 October 2024, 09:30 (CEST) to 22 October 2024, 17:00 (CEST)
Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)
Submitted by Anonymous (not verified) on 10 February 2025 - 11:08
Members of the Coordinating group of European network of paediatric research at the European Medicines Agency (Enpr-EMA)
Advice to medical device manufacturers - 2025 Timetable
Submitted by Anonymous (not verified) on 10 February 2025 - 11:04
Advice to medical device manufacturers - 2025 Timetable
Request for advice on the clinical development strategy and / or clinical investigations according to Article 61(2) of Regulation (EU) 2017/745 on from the medical device expert panels
Submitted by Anonymous (not verified) on 10 February 2025 - 11:03
Request for advice on the clinical development strategy and / or clinical investigations according to Article 61(2) of Regulation (EU) 2017/745 on from the medical device expert panels